Primary Device ID | B800PSYCH2FMACL5 |
NIH Device Record Key | 83cf8d7b-4b0b-42ec-a594-4010925f5ae5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PSYCH PANEL LEVEL 2 |
Version Model Number | PSYCH 2 F M ACL |
Catalog Number | PSYCH 2 F M ACL |
Company DUNS | 092519016 |
Company Name | UTAK LABORATORIES, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com | |
Phone | 1-888-882-5522 |
welovecontrol@utak.com |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 10 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B800PSYCH2FMACL0 [Primary] |
HIBCC | B800PSYCH2FMACL5 [Package] Contains: B800PSYCH2FMACL0 Package: Box [25 Units] In Commercial Distribution |
LAS | Drug Specific Control Materials |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-24 |
Device Publish Date | 2024-04-16 |
B800TESTO2WBMTL5 - TESTOSTERONE PLUS LEVEL 2 | 2024-05-09 TESTOSTERONE PLUS LEVEL 2 |
B800THC0UFWDH5 - THC LEVEL 0 | 2024-05-09 THC LEVEL 0 |
B800THC10UFWDH5 - THC LEVEL 10 | 2024-05-09 THC LEVEL 10 |
B800THC11UFWDH5 - THC LEVEL 11 | 2024-05-09 THC LEVEL 11 |
B800THC12UFWDH5 - THC LEVEL 12 | 2024-05-09 THC LEVEL 12 |
B800THC1UFWDH5 - THC LEVEL 1 | 2024-05-09 THC LEVEL 1 |
B800THC2UFWDH5 - THC LEVEL 2 | 2024-05-09 THC LEVEL 2 |
B800THC3UFWDH5 - THC LEVEL 3 | 2024-05-09 THC LEVEL 3 |